Drug product
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
D-0757-2021
Product summary
- Event
- Event 88457
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,161 (50mg and 100 mg vials total)
- Official record key
drug-enforcement:D-0757-2021
Official wording
Reason: Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Code information: Lot 467111, exp 1/2023
Distribution pattern: Nationwide USA
Derived failure modes
-
Labeling or packaging
Labeling; Incorrect or Missing